There was no substantially different risk for incident atrial fibrillation (AF) or major adverse cardiovascular events (MACE) after beginning treatment with ustekinumab vs tumor necrosis factor inhibitors (TNFis), according to study results published in JAMA Dermatology.

In this cohort study, investigators identified patients age ≥18 years
with psoriasis or psoriatic arthritis from multiple databases (N=60,028). The
patients had started therapy with ustekinumab (n=9071) or TNFi (n=50,957)
initiators and were required to have 12 months of continuous enrollment before
the date of treatment initiation. Investigators followed the patients from this
index date until the first occurrence of 1 of the outcomes of interest (AF or
MACE), death, plan disenrollment, discontinuation of treatment, or the end of
the study period. More than 60 predefined variables potentially associated with
psoriatic disease severity and cardiovascular severity were measured during the
12-month baseline period.

After a mean follow-up of 1.4±1.3 years, there were 383 total diagnoses of incident AF (60 in patients being treated with ustekinumab and 323 in patients treated with TNFi initiators). Reported per 1000 person-years, the overall crude incidence rates for AF were 5 (95% CI, 3.8-6.5) in patients taking ustekinumab and 4.7 (95% CI, 4.2-5.2) in patients taking TNF initiators. The combined adjusted hazard ratio for ustekinumab initiators was 1.08 (95% CI, 0.76-1.54) for incident AF and 1.1 (95% CI, 0.8-1.52) for MACE when compared with TNFi initiators. A total of 495 cases of MACE were observed during follow-up in patients taking ustekinumab (n=74) and TNFis (n=421). The overall crude incidence rates were 6.2 (95% CI, 4.9-7.8) in the ustekinumab group and 6.1 (95% CI, 5.5-6.7) in the TNFi group.

This study may be limited by potentially unmeasured or incompletely
measured confounders, as is the case in any observational study. The key
strength of this study is its large sample size of a diverse patient
population.

Investigators found no overall differential risk for incident AF and
MACE associated with the use of ustekinumab or TNFi. These findings are
consistent with previous findings of no substatial difference in risk for
cardiovascular events associated with the use of these biologic therapies and
may serve as a hypothesis-generating basis for assessing the differential
effects of these treatments.

Multiple
authors declare affiliations with the pharmaceutical industry. Please refer to
reference for a complete list of authors’ disclosures.